In 2018, 12 patients were hospitalized for infections caused by contaminated ReGen Series stem cell products manufactured by Genetec and distributed by Liveyon. On September 18, 2018, Liveyon initiated a voluntary recall of all Genetec-produced products and no longer uses the manufacturer. E. coli was among the bacteria which caused the infections in the hospitalized patients. There were no deaths involved.
FDA Warning Letters
The contaminated stem cell products utilized stem cells derived from umbilical cords processed by Genetec. In November 2018, the U.S. Food and Drug Administration (FDA) sent a warning letter to Genetec stating that its safety standards, including donor screening and in the manufacturing process, were in adequate.
In December, 2018, the FDA sent warning letters to 20 more stem cell companies letting them know that the agency intends to ramp up enforcement of guidelines for stem cell-based regenerative medicine, and reminding them “that the 36-month period during which FDA intends to exercise enforcement discretion will end in November 2020.”
In a January 28, 2018 announcement, the U.S. Centers for Disease Control and Prevention (CDC) said that it is investigating the infections in patients who received the recalled ReGen Series stem cell products. It stated that most of the infected patients experienced symptoms within a few days of receiving the products. Symptoms included:
It also mentioned that although one of the deficiencies noted in the FDA latter to Genetec was failure to screen donors for HIV, hepatitis B, and hepatitis C, the CDC is not yet aware of any infection with any of the three associated with the ReGen Series products.
If you believe that your injuries were caused by contaminated or otherwise defective stem cell products, please schedule a free consultation with an experienced defective medical product attorney right away to learn more about your rights.